1. Field of the Invention
This invention relates to analgesic compositions and methods of producing analgesia in mammals and more particularly to nalbuphine-narcotic analgesic oral compositions for producing analgesia in mammals.
2. Prior Art
U.S. Pat. No. 3,393,197 issued to Pachter and Matossian on July 16, 1968 discloses N-substituted-14-hydroxydihydronormorphines, including the N-cyclobutylmethyl derivatives, commonly called nalbuphine: ##STR1## Pachter and Matossian and others, such as H. W. Elliott, et al., J. Med. (Basel), 1, 74-89 (1970); H. Blumberg, et al., Pharmacologist, 10, 189, Fall 1968; P. Roberts, Drugs of the Future, 2, 613-5 (1977), disclose the use of nalbuphine as an analgesic for the control of moderate to severe pain.
U.S. Pat. No. 4,237,140, issued to J. R. Dudzinski on Dec. 2, 1980, describes an analgesic mixture of nalbuphine and acetoaminophen. U.S. Pat. No. 4,282,215, issued to J. R. Dudzinski and W. K. Schmidt on Aug. 4, 1981, describes an analgesic mixture of nalbuphine and aspirin.
Morphine, oxymorphone, oxycodone and hydromorphone are well known strong narcotic analgesics which can, unfortunately, be addictive and/or euphoric and subjected to abuse by parenteral administration. Furthermore, these narcotics tend to produce respiratory depression in patients, especially when given as part of anesthesia. One attempt to minimize abuse of these and other strong analgesic agents is described in U.S. Pat. No. 3,773,955, issued to Pachter and Gordon on Nov. 20, 1973 (also U.K. Pat. No. 1,353,815) wherein a combination of a parenterally effective but orally ineffective dose of naloxone and an analgetic agent gives an orally effective, but parenterally inactive analgesic composition. While naloxone will overcome the narcotic analgesic upon parenteral administration to reduce respiratory depression, euphoria and other side effects, it also eliminates analgesia. Such a composition upon oral administration provides analgesia, but the naloxone is inactive orally such that there is no reduction in side effects.
B. J. Kripke et al., J. of the International Anesthesia Research Society, Vol. 55, No. 6, pages 800-805 November-December 1976, describe naloxone antagonism after narcotic-supplemented anesthesia.